NPI Compliance Specialist

Overview

NPI Compliance Specialist - Sligo, Ireland - 12 Month Contract

Located on the picturesque west coast of Ireland, our global pharmaceutical client is looking for an NPI Compliance Specialist to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people's lives. They have 50,000 employees around the world and are continuing to grow.

What you'll do

• To ensure new products are manufactured following applicable regulatory requirements and policies.
• Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system.
• NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.
• Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage.
• Support review and approval of NPI related Analytical Test Method Transfers and/or validation.

What you'll need

• A third level qualification in a science, quality or relevant discipline.
• A minimum of three years experience in a quality role supporting new product introductions.
• Strong knowledge of regulatory requirements is required.
• Regulatory, quality and New product introduction background.
• Extensive experience gained within an aseptic processing environment, ideally gained within a quality function.

Note: This description contains the core responsibilities and qualifications for the role. If this role is of interest, please apply through the appropriate channel.